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OpenTrials
Completed

NCT Number: NCT04767464

Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups

The Compass Course (CC) is a group intervention designed for individuals with Breast Cancer. Over the course of 8 face-to-face group sessions, the CC is designed to help participants reclaim a sense of self-grounded purpose in daily life, defined as intentional use of time and energy in ways that align with one's values, strengths, and sources of personal meaning (e.g., inner compass) in the moments that compose a day. Because of COVID-19, in-person groups are discouraged and so we need to identify new ways to provide group-based interventions that are feasible and efficacious.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasm 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

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55447, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to attend intervention sessions for 9 weeks on Monday or Tuesday afternoons (4:30 - 6:30 pm) starting Monday, April 5, 2021
  • 25 years of age or older
  • Completed chemotherapy and/or radiation treatment for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention
  • English speaking
  • Graduated from high school
  • 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
  • Access to computer or tablet and adequate internet connection to participate in video conference

Exclusion criteria

  • Stage 4 breast cancer or any other 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

Other

The Compass Course is an 8-session group course designed to address purpose in life of those with Breast Cancer. Enrollment in this arm will involve participation in the Compass Course virtually.

Primary outcomes

  1. Change in Scales of Psychological Wellbeing

    Time frame: Through Study Completion (about 4 Months)

    A widely-used self-report questionnaire that was designed to measure 6 theoretically motivated dimensions of psychological well-being (autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, self-acceptance).

  2. Change in Meaning in Life Questionnaire

    Time frame: Through Study Completion (about 4 Months)

    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).

  3. Change in Engagement in Meaningful Activities survey

    Time frame: Through Study Completion (about 4 Months)

    A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.

  4. Change in Purpose Status Question

    Time frame: Through Study Completion (about 4 Months)

    A single forced-choice self-report screener question that we developed in order to characterize existential distress related to purpose in life.

Secondary outcomes

  1. Change in Beck Depression Inventory -- II

    Time frame: Through Study Completion (about 4 Months)

    A 21-question, widely-used self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  2. Change in State-Trait Anxiety Inventory

    Time frame: Through Study Completion (about 4 Months)

    A self-report questionnaire composed of 20 state and 20 trait statements related to anxiety. We will use the 20-item State inventory (1-4 scale).

Sponsors and collaborators

Lead sponsor

Mary Radomski

Other

Registry information

Acronym: CC-V

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
Nov 14, 2023

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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