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

Breast Cancer Clinical Trial

— CC-V  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767464
• Other study ID #: CKRC2021-CCV
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 7, 2023
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

1. Able to attend intervention sessions for 9 weeks on Monday or Tuesday afternoons (4:30

• 6:30 pm) starting Monday, April 5, 2021

2. 25 years of age or older

3. 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

4. English speaking

5. Graduated from high school

6. Able to see, hear, speak (with or without assistive devices)

7. Able to provide own transportation to sessions

8. Willing and able to commit to attend all 8 intervention sessions

9. Access to computer or tablet and adequate internet connection to participate in video conference

Exclusion Criteria:

1. Stage 4 breast cancer or any other 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms

Intervention

Other:
• Compass Course
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.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mary Radomski

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Scales of Psychological Wellbeing	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).	Through Study Completion (about 4 Months)
Primary	Change in Meaning in Life Questionnaire	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).	Through Study Completion (about 4 Months)
Primary	Change in Engagement in Meaningful Activities survey	A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.	Through Study Completion (about 4 Months)
Primary	Change in Purpose Status Question	A single forced-choice self-report screener question that we developed in order to characterize existential distress related to purpose in life.	Through Study Completion (about 4 Months)
Secondary	Change in Beck Depression Inventory -- II	A 21-question, widely-used self-report rating inventory that measures characteristic attitudes and symptoms of depression.	Through Study Completion (about 4 Months)
Secondary	Change in State-Trait Anxiety Inventory	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).	Through Study Completion (about 4 Months)