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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Compass Course||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|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)|
|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|
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.
- 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.
- 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
- 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.
- 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.
- Time of post-testing session [ Time Frame: Duration of session 8 (at week 12), approximately 1 hour ]Actual length (in minutes) of testing session.
- Homework completion [ Time Frame: Each week from week 2 through week 8 ]Whether or not homework was attempted
- Intervention fidelity [ Time Frame: Each week from week 2 through week 8 ]Which key intervention elements were provided during a given session
- 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).
- 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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Mary Radomski, PhD, OTR/L||Allina Health|