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Completed

NCT Number: NCT03442686

Compass Course: Efficacy Study

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Courage Kenny Rehabilitation Institute, Golden Valley, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 25 years of age or older
  • 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
  • English speaking
  • High school diploma or GED
  • Able to see, hear, speak (with or without assistive devices)
  • Able to provide own transportation to sessions
  • Willing and able to commit to attend all 8 intervention sessions

Exclusion criteria

(all self-reported):

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

Treatment and study plan

Compass Course

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2018
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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