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Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer (MAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04559854
Recruitment Status : Completed
First Posted : September 23, 2020
Last Update Posted : December 3, 2020
Sponsor:
Collaborator:
OHSU Knight Cancer Institute
Information provided by (Responsible Party):
Oregon State University

Study Description
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Brief Summary:
The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

Condition or disease Intervention/treatment Phase
Breast Cancer Gynecologic Cancer Behavioral: Mindful After Cancer Not Applicable

Detailed Description:
The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sexual Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindful After Cancer
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
 Behavioral: Mindful After Cancer
The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility/ Enrollment [ Time Frame: Baseline ]
    Number of participants enrolled, Proportion of participants enrolled of those eligible

  2. Feasibility/ Retention in Study [ Time Frame: 1 month post-intervention ]
    Number and proportion of participants completing all assessments

  3. Feasibility/ Retention in the Program [ Time Frame: 1 month post-intervention ]
    Mean number of sessions attended, Proportion of participants attending at least 6 of 8 sessions

  4. Acceptability [ Time Frame: 1 month post-intervention ]
    Endorsement of 10 items characterizing acceptability (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.


Secondary Outcome Measures :
  1. Change from baseline self-efficacy at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    Self-efficacy for Managing Chronic Disease Scale (adapted). 6 items. Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer.

  2. Change from baseline body image at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.

  3. Change from baseline body appreciation at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.

  4. Change from baseline anxiety at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Raw scores are translated to a T score following PROMIS guidelines. Higher score indicates greater anxiety symptoms.

  5. Change from baseline depression at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms

  6. Change in facets of baseline mindfulness at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    Five-Facet Mindfulness Questionnaire (FFMQ-15). 15 items with 5 sub-scales: Observe, Describe; Act with Awareness; Non-Judgement, Non-Reactivity. Sub-scale score range 3-15. Higher score indicates greater mindfulness.

  7. Change from baseline self-compassion at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    Self-Compassion Scale short form. 12 items. Range 12-60. Higher score indicates greater self-compassion.

  8. Change from baseline relationship quality at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality

  9. Change from baseline interest in sexual activity at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    PROMIS SexFS 2.0. 2 items. Range 2-10. Raw scores are translated to a T score following PROMIS guidelines. Higher score indicates more interest in sexual activity.

  10. Change from satisfaction with sex life at 1 month [ Time Frame: Baseline and 1 month post-intervention ]
    New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
  • English speaking
  • Have access to a computer, smart phone, or tablet with internet access
  • Ability to spend 15-30 minutes per day on program activities

Exclusion Criteria:

- Stage 0 (carcinoma in situ)

Contacts and Locations
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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): NCT04559854


Locations
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United States, Oregon
Oregon State University
Corvallis, Oregon, United States, 97331
Sponsors and Collaborators
Oregon State University
OHSU Knight Cancer Institute
Investigators
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Principal Investigator: Jessica R Gorman, PhD, MPH Oregon State University
More Information
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Responsible Party: Oregon State University
ClinicalTrials.gov Identifier: NCT04559854    
Other Study ID Numbers: 20181004
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020

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