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Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups (CC-V)

Primary Purpose

Breast Cancer, Breast Neoplasm

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compass Course
Sponsored by
Mary Radomski
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Purpose

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Abbott Northwestern Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Compass Course

Arm Description

Virtual Compass Course

Outcomes

Primary Outcome Measures

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).
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).
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.
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.

Secondary Outcome Measures

Change in Beck Depression Inventory -- II
A 21-question, widely-used self-report rating inventory that measures characteristic attitudes and symptoms of depression.
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).

Full Information

First Posted
February 11, 2021
Last Updated
June 6, 2022
Sponsor
Mary Radomski
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1. Study Identification

Unique Protocol Identification Number
NCT04767464
Brief Title
Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups
Acronym
CC-V
Official Title
Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mary Radomski

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasm
Keywords
Purpose

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary V Radomski, OTR/L, PhD
Organizational Affiliation
Senior Scientific Advisor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55447
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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