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Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05235750
Recruitment Status : Recruiting
First Posted : February 11, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
A diagnosis of cancer may challenge one's former assumptions and beliefs about themselves and the world and potentially compromise quality of life (QOL). The primary aim of the study is to explore the preliminary efficacy of an intervention to protect individuals from the negative psychological impact of the cancer diagnosis. The secondary aim is to test the validity of the 12-item Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp-12), in its current and revised forms. Potential participants will be referred and enrolled from two study sites as per protocol: the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) and the Arkansas Hospice respectively, and will be asked to write as guided by the researcher for 4 weeks. Study outcomes will be assessed at baseline, 2-, 6- and 8-weeks post baseline. It is hypothesized that self-affirmation at the time following a diagnosis of an advanced cancer by affirming values or beliefs that are salient to self will help enhance self-esteem, reinforce spiritual well-being, decrease levels of anxiety or depression, and improve QOL.

Condition or disease Intervention/treatment Phase
Neoplasms Behavioral: Self-affirmation writing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer: A Preliminary Efficacy Trial
Actual Study Start Date : May 27, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Experimental: Writing
This is a single-group study with one arm only.
Behavioral: Self-affirmation writing
Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer




Primary Outcome Measures :
  1. Mean Changes from Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline [ Time Frame: Baseline as well as 2-, 6-, and 8 weeks post baseline ]
    Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem.

  2. Mean Changes from Baseline in Quality of Life Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline [ Time Frame: Baseline as well as 2-, 6-, and 8 weeks post baseline ]
    Changes include raw score changes and standardized mean differences. Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) range from 0 to 108, with higher score indicating higher level of quality of life.


Secondary Outcome Measures :
  1. Mean Changes from Baseline in Spiritual Well-Being Scores on the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline [ Time Frame: Baseline as well as 2-, 6-, and 8 weeks post baseline ]
    Changes include raw score changes and standardized mean differences. Scores on the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp-12) range from 0 to 48, with higher score indicating higher level of spiritual well-being.

  2. Mean Changes from Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline [ Time Frame: Baseline as well as 2-, 6-, and 8 weeks post baseline ]
    Changes include raw score changes and standardized mean differences. Scores on the Hospital Anxiety and Depression Scale (HADS) range from 0 to 42, with higher score indicating higher level of anxiety or depression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • within 8 weeks of being informed of diagnosis (primary or recurrent)
  • cancer stage III or IV of a primary solid tumor, or a high-grade hematological malignancy, and
  • age 18 years or older

Exclusion Criteria:

  • medical condition precluding participation (e.g., too ill or fatigued, acute mental confusion as determined by the treating physician), or
  • enrolled in other psychosocial experiments

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): NCT05235750


Contacts
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Contact: Priscilla Newman 501-686-8274 newmanpriscilla@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Priscilla Newman    501-686-8274    newmanpriscilla@uams.edu   
Arkansas Hospice Recruiting
North Little Rock, Arkansas, United States, 72116
Contact: Brian W. Bell, M.D.    501-748-3333    bbell@arkansashospice.org   
Sponsors and Collaborators
University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT05235750    
Other Study ID Numbers: 273876
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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