NCT04767464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

February 11, 2021

Last Update Submit

November 10, 2023

Conditions

Breast CancerBreast Neoplasm

Keywords

Purpose

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Change in Beck Depression Inventory -- II

    Through Study Completion (about 4 Months)

  • Change in State-Trait Anxiety Inventory

    Through Study Completion (about 4 Months)

Study Arms (1)

Compass Course

OTHER

Virtual Compass Course

Other: Compass Course

Interventions

Compass CourseOTHER

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.

Compass Course

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to attend intervention sessions for 9 weeks on Monday or Tuesday afternoons (4:30 - 6:30 pm) starting Monday, April 5, 2021
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55447, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mary V Radomski, OTR/L, PhD

    Senior Scientific Advisor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Scientific Advisor

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 23, 2021

Study Start

March 1, 2021

Primary Completion

February 15, 2022

Study Completion

November 7, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)