Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

NCT ID: NCT01582971

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-17
• Study Completion Date: 2016-05-31

Brief Summary

The purpose of this project is to test foot reflexology delivered by a friend or family member in the home for women with breast cancer. The primary aims of the proposed study in a sample of women with breast cancer receiving chemotherapy and/or hormonal therapy are to determine the effects of 4 family- or friend-delivered weekly reflexology sessions compared to an attention control group.

Detailed Description

This project tests the benefits of a home-based intervention of foot reflexology for improving health-related quality of life (HRQOL) including symptom responses, functioning, and health perceptions in women treated with chemotherapy for advanced breast cancer. Reflexology applies a firm walking-motion during sessions and is based on the premise that the foot has reflexes mirroring organs of the body. Symptom burden is the strongest predictor of HRQOL for cancer patients. This project brings together expertise from nursing, reflexology, communication, statistics, and health economics. The primary specific aims, in a sample of women with advanced breast cancer receiving chemotherapy, are to determine the effects of a 4-week, home-based reflexology intervention delivered by a friend/family provider compared to attention control for improvement of:

1. HRQOL including symptoms, functioning, and health perception at study weeks 5 and 11.

The investigators hypothesize that the reflexology group will have better HRQOL (symptoms, functioning, and health perception) than the attention control group at study weeks 5 and 11.

2. Multiple symptom responses and times-to-response as determined by weekly symptom assessments during the 4-week intervention time.

The investigators hypothesize that the reflexology group will have a higher proportion of symptoms that respond to the intervention and shorter time-to-symptom-responses than the attention control group.

3. Symptom-related use of unscheduled health services during the 11-week study. The investigators hypothesize that fewer unscheduled services will be used for symptom management over the 11-week study period by women receiving reflexology compared to women in the attention control.

The exploratory aims are to: 1) Explore differences between trial arms in perceptions of social support due to the family- or friend-delivered reflexology sessions at study weeks 5 and 11; 2) Determine if effects of the reflexology intervention on HRQOL are mediated by social support; and 3) Use the newly developed NIH PROMIS standardized symptom and functioning instruments to assess the effects of the reflexology intervention and to compare the responsiveness of PROMIS instruments and existing instruments designed to measure similar constructs.

This project has immense potential to make an effective symptom management intervention accessible to patients in their homes via a friend or family home provider. The investigators will not only intervene to enhance HRQOL but also to evaluate social support and costs associated with unscheduled health services. Effective symptom management provides time and cost savings to clinicians, advances the current state-of-the-science, and promotes adherence to medical treatment that may ultimately enhance survival.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: OTHER

Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient

Control

Standard medical care: no reflexology

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reflexology

Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 21
• Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence
• Able to perform basic ADLs
• Undergoing chemotherapy and/or hormonal therapy for breast cancer
• Able to speak and understand English
• Have access to a telephone
• Able to hear normal conversation
• Cognitively oriented to time, place, and person (determined via nurse recruiter)

Exclusion Criteria

• Diagnosis of major mental illness on the medical record and verified by the recruiter
• Residing in a nursing home
• Bedridden
• Currently receiving regular reflexology
• Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Gwen Wyatt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gwen Wyatt, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Northwestern

Chicago, Illinois, United States

Hurley Medical Center

Flint, Michigan, United States

Lemmon-Holton Cancer Center

Grand Rapids, Michigan, United States

Breslin Cancer Center

Lansing, Michigan, United States

Sparrow Cancer Center

Lansing, Michigan, United States

McLaren Macomb

Mount Clemens, Michigan, United States

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Beaumont Hospital

Royal Oak, Michigan, United States

St. Johns Providence

Warren, Michigan, United States

Countries

United States

References

Sikorskii A, Niyogi PG, Victorson D, Tamkus D, Wyatt G. Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer. Support Care Cancer. 2020 Mar;28(3):1395-1404. doi: 10.1007/s00520-019-04959-y. Epub 2019 Jul 2.

Reference Type: DERIVED

PMID: 31267277 (View on PubMed)

Luo Z, Wang L, Sikorskii A, Wyatt G. Healthcare service utilization and work-related productivity in reflexology intervention for advanced breast cancer women. Support Care Cancer. 2019 Aug;27(8):2837-2847. doi: 10.1007/s00520-018-4592-4. Epub 2018 Dec 14.

Reference Type: DERIVED

PMID: 30552595 (View on PubMed)

Other Identifiers

1R01CA157459-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R01CA157459-01

Identifier Type: NIH

Identifier Source: org_study_id

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