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Efficacy of a Couple-Focused mHealth Symptom Self-management Program

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ClinicalTrials.gov Identifier: NCT03489057
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 250 patients completing initial treatment for localized prostate cancer and their intimate partners.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Prostate Cancer Education and Resources for Couples (PERC) Behavioral: usual care plus NCI website Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The investigator and data collectors will be masked to intervention.
Primary Purpose: Supportive Care
Official Title: Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: PERC Program
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.
Behavioral: Prostate Cancer Education and Resources for Couples (PERC)
PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.

Active Comparator: usual care plus NCI website
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Behavioral: usual care plus NCI website
The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.




Primary Outcome Measures :
  1. Change in quality of life over time as assessed by Functional Assessment of Cancer Treatment (FACT-G) scores [ Time Frame: Baseline, month 12 ]
    FACT-G will be used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General (FACT-G) is a 27 item survey which assesses physical, social/family, emotional, and functional well being on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. Higher scores indicate better well-being.


Secondary Outcome Measures :
  1. Change in Pain from baseline to 4-, 8-, and 12-month post baseline as assessed by Patient-Reported Outcome Measurement Information System (PROMIS) scores [ Time Frame: Baseline, month 4, 8, and 12 ]
    PROMIS Pain Interference - Short Form 6b will be used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference.

  2. Change in Fatigue from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores [ Time Frame: Baseline, month 4, 8, and 12 ]
    PROMIS Fatigue -Short Form 7a will be used to measure change in Fatigue among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The fatigue sub-scale will measure the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue.

  3. Change in sleep disturbance from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores [ Time Frame: Baseline, month 4, 8, and 12 ]
    PROMIS Sleep Disturbance Short Form 8b will be used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The sleep disturbance sub-scale measures the extent to which participant experience sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance.

  4. Change in Anxiety from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Anxiety Short Form [ Time Frame: Baseline, month 4, 8, and 12 ]
    PROMIS-Emotional Distress-Anxiety Short Form 7a will be used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale, where higher scores reflect higher anxiety.

  5. Change in depression from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Depression [ Time Frame: Baseline, month 4, 8, and 12 ]
    PROMIS-Emotional Distress-Depression Short From 8b will be used to measure change in depression scores among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale, where higher scores indicate greater depressive symptoms.

  6. Change in prostate cancer patient function and bother scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: Baseline, month 4, 8, and 12 ]
    The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in health related quality of life scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value. It contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.

  7. Change in caregiver ratings of how patient's prostate cancer related symptoms affect their own life from baseline to 4-, 8-, and 12-month post baseline as assessed by the Prostate Cancer Related Symptoms Caregiver Short Form [ Time Frame: Baseline, month 4, 8, and 12 ]
    The Prostate Cancer Related Symptoms Caregiver Short Form will be used to measure changes in caregiver scores from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value.The questionnaire is a 4-item assessment about how the patient's hormone, sexual, bowel, and urinary function has affected the caregiver over the past 4 weeks. Items are ranked on a 5-point Likert Scale where higher scores indicate greater bother associated with the patient's symptoms.

  8. Change in self-efficacy scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Lewis Cancer Self-Efficacy scale [ Time Frame: Baseline, month 4, 8, and 12 ]
    The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.

  9. Change in Informational Support scores from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Informational Support Short Form [ Time Frame: Baseline, month 4, 8, and 12 ]
    PROMIS Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

  10. Change in Emotional Support System scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS-Emotional support [ Time Frame: Baseline, month 4, 8, and 12 ]
    The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

  11. Change in Instrumental Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS Instrumental Support-Short Form 8a [ Time Frame: Baseline, month 4, 8, and 12 ]
    The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

  12. Change in Interpersonal Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by Interpersonal Support Evaluation List -12 (ISEL-12) [ Time Frame: Baseline, month 4, 8, and 12 ]
    The ISEL-12 will be used to measure change in social support from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1) among patients and their partners. The ISEL-12 is a 12 item measure, where higher scores indicate greater social support. Change from baseline is the post-Baseline values minus the Baseline value.

  13. Change in Appraisal of Illness scores from baseline to 4-, 8-, and 12-month post baseline as measured by Appraisal of Illness scale [ Time Frame: Baseline, month 4, 8, and 12 ]
    Appraisal of Illness scale will be used to measure change in perception of prostate cancer and related issues among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.The Appraisal of Illness scale is a 20 item measure that uses Likert Scales ranging from Very False to Very True.

  14. Change in Dietary Risk Assessment scores from baseline to 4-, 8-, and 12-month post baseline as measured by Dietary Risk Assessment scale [ Time Frame: Baseline, month 4, 8, and 12 ]
    Change in Dietary Risk Assessment scores will be used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients and their partners will be asked how often they consume different foods over the past month or week and will respond using a Likert Scale to report how much of each food item they have consumed.

  15. Change in Older Adult's Sedentary Time from baseline to 4-, 8-, and 12-month post baseline as measured by Measure of Older Adult's Sedentary Time (MOST) [ Time Frame: Baseline, month 4, 8, and 12 ]
    The Measure of Older Adult's Sedentary Time will be used to measure change in self-reported sedentary time from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants will self-report how much time they spend doing various sedentary activities during the past week.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The eligible patients must

  1. be 40 to 75 years of age
  2. be within 4 months after completing initial treatment for localized prostate cancer as confirmed by hospital medical record) with curative intent, i.e., surgery or radiotherapy +/- hormonal treatment;
  3. have no other prior or concurrent cancer;
  4. experience prostate cancer-specific and/or general symptoms;
  5. have a partner who is willing to participate.

The eligible partners must

  1. be 18 years or older
  2. be identified as the partner by the patient
  3. not have been diagnosed with cancer or receiving treatment for cancer within the past 12 months so that couples can focus their efforts on managing prostate cancer.

Exclusion Criteria:

Patients and their partners will be excluded from the study if they:

  • Do not read and speak English (evidenced by their understanding and responses to screening questions and self-reported ability to read English);
  • Have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489057


Contacts
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Contact: Lixin Song, RN, PhD 919-966-3612 lsong@unc.edu
Contact: Frederic W. Fuller, RN BA 919-966-3119 ffuller@email.unc.edu

Locations
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United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27559
Contact: Lixin Song, PhD    919-966-3612    lsong@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Lixin (Lee) Song, RN, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03489057     History of Changes
Other Study ID Numbers: 17-0482
1R01NR016990-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
symptom
family research
self-management
caregiving
social support
mHealth
healthy behavior
self-efficacy
quality of life
care transition

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases