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Compass Course: Efficacy Study

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: NCT03442686
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Radomski, Allina Health System

Brief Summary:
The Compass Course is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of breast cancer survivors to evaluate the efficacy of the Compass Course intervention.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Compass Course Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study uses a wait list control design. One group of participants will be evaluated before receiving the intervention (in Spring 2018) and compared to those who receive the intervention in Spring 2018. The first group will go on to receive the intervention in Fall 2018.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Compass Course: Efficacy Study
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spring 2018 Compass Course Group
Two groups of up to 15 participants (30 total) will receive the study intervention during Spring 2018. All participants will complete study questionnaires before and after the Spring sessions.
Behavioral: Compass Course
An 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives.

No Intervention: Spring 2018 Comparison Group
Two groups of up to 15 participants will receive the study intervention in Fall 2018. All participants will complete study questionnaires before and after the Spring sessions. Those who enroll in the study and agree to participate in the Fall sessions will serve as a no-treatment comparison group.



Primary Outcome Measures :
  1. Change in psychological well-being [ Time Frame: Will be administered at Week 0 (pre-testing), at Week 12 (session 8), and at 3 month follow up ]
    Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.


Secondary Outcome Measures :
  1. Recruitment [ Time Frame: Up to 1 month after IRB approval ]
    Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study

  2. Time of pre-testing session [ Time Frame: Duration of pre-testing session (approximately 2 hours) at week 0 to week 1 ]
    Actual length (in minutes) of pre-testing session.

  3. Time of testing session [ Time Frame: Each week from week 2 through week 8, approximately 2 hours at each session ]
    Actual length (in minutes) of testing session.

  4. Time of post-testing session [ Time Frame: Duration of session 8 (at week 12), approximately 1 hour ]
    Actual length (in minutes) of testing session.

  5. Homework completion [ Time Frame: Each week from week 2 through week 8 ]
    Whether or not homework was attempted

  6. Intervention fidelity [ Time Frame: Each week from week 2 through week 8 ]
    Which key intervention elements were provided during a given session

  7. Change in Meaning in life [ Time Frame: At week 0 and at week 12, and at 3 month follow up ]
    Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).

  8. Engagement in Meaningful Activities [ Time Frame: At week 0 and at week 12 ]
    Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.

  9. Purpose Status and Expectations [ Time Frame: At week 0, at week 12, and at 3 month follow up ]
    A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.

  10. Participant Experience of Compass Course [ Time Frame: At week 12 and at week 14-20 ]
    Participant experience of Compass Course as measured by self-report questionnaire and post-intervention focus group.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. 25 years of age or older
  2. Completed treatment (such as chemotherapy, radiation, surgery) for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention
  3. English speaking
  4. High school diploma or GED
  5. Able to see, hear, speak (with or without assistive devices)
  6. Able to provide own transportation to sessions
  7. Willing and able to commit to attend all 8 intervention sessions

Exclusion criteria (all self-reported):

  1. Stage 4 breast cancer or any other stage 4 cancer
  2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
  3. History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
  4. Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

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): NCT03442686


Locations
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United States, Minnesota
Courage Kenny Rehabilitation Institute
Golden Valley, Minnesota, United States, 55422
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Allina Health Shoreview Clinic
Shoreview, Minnesota, United States, 55126
Sponsors and Collaborators
Allina Health System
Investigators
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Principal Investigator: Mary Radomski, PhD, OTR/L Allina Health

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Responsible Party: Mary Radomski, Senior Scientific Advisor, Allina Health System
ClinicalTrials.gov Identifier: NCT03442686     History of Changes
Other Study ID Numbers: CKMW-1801
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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