NCT03233334

Brief Summary

The Purpose Project intervention 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 women with breast cancer to evaluate the feasibility of the Purpose Project intervention in terms of demand/acceptability, implementation, and limited-efficacy testing. Findings will be used to inform a later study to evaluate the efficacy of the Purpose Project intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable breast-cancer

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 24, 2017

Last Update Submit

July 1, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in psychological well-being

    Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, \& Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.

    Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).

Secondary Outcomes (11)

  • Recruitment

    Up to 1 month after IRB approval

  • Time of pre-testing session

    Duration of pre-testing session (approximately 2 hours) at week 0 to week 1

  • Time of testing session

    Each week from week 2 through week 8, approximately 2.5 hours at each session

  • Time of post-testing session

    Duration of session 8 (at week 12), approximately 2 hours

  • Homework completion

    Each week from week 2 through week 8

  • +6 more secondary outcomes

Study Arms (1)

Purpose Project Group

EXPERIMENTAL

Group receiving Purpose Project intervention.

Behavioral: Purpose Project

Interventions

Purpose ProjectBEHAVIORAL

The purpose project intervention 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 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 life that helps them flourish.

Purpose Project Group

Eligibility Criteria

Age25 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 25 and 74 years of age
  • Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment
  • 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, 2 testing sessions, and the one-to-one interview that occurs after completing the 8 intervention sessions.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mary Radomski, PhD, OTR/L

    Allina Health

    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
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientific Advisor

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 28, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

January 31, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)