Kindness Interventions in Enhancing Well-Being in Breast Cancer Survivors

NCT ID: NCT03319342

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2019-12-03

Brief Summary

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Emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. This randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use with early-stage breast cancer survivors.

Detailed Description

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PRIMARY OBJECTIVES:

I. To refine two interventions - loving kindness and acts of kindness- for use with breast cancer survivors using an online platform.

II. To determine the feasibility and preliminary efficacy of these interventions on positive affect, depressive symptoms, and other aspects of well-being among women with breast cancer.

OUTLINE: Participants are randomized to 1 of 4 groups.

GROUP I (ACTS OF KINDNESS TO OTHERS): Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP II (ACTS OF KINDNESS TO SELF): Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP III (SELF-KINDNESS MEDITATION): Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP IV (CONTROL): Participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires.

Conditions

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Cancer Survivor Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (acts of kindness to others)

Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Perform acts of kindness to others

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (acts of kindness to self)

Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Perform acts of kindness to self

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group III (self-kindness meditation)

Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Perform self-kindness meditation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group IV (track daily activities)

Participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires.

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

Keep track of daily activities

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Intervention

Perform acts of kindness to others

Intervention Type BEHAVIORAL

Behavioral Intervention

Perform acts of kindness to self

Intervention Type BEHAVIORAL

Behavioral Intervention

Perform self-kindness meditation

Intervention Type BEHAVIORAL

Behavioral Intervention

Keep track of daily activities

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy behavior modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification BEHAVIORAL THERAPY Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy behavior modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification BEHAVIORAL THERAPY Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy behavior modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification BEHAVIORAL THERAPY Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy behavior modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification BEHAVIORAL THERAPY Behavioral Treatment Behavioral Treatments

Eligibility Criteria

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Inclusion Criteria

* Women previously diagnosed with stage 0-IIIA breast cancer
* Have completed treatment with surgery, radiation, and/or chemotherapy
* Have not had a cancer recurrence
* Have access to the internet and an active email account
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julienne Bower

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

University of California-Riverside

Riverside, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-01469

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCCCID776

Identifier Type: -

Identifier Source: secondary_id

17-000560

Identifier Type: OTHER

Identifier Source: secondary_id

17-000560

Identifier Type: -

Identifier Source: org_study_id

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