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Integrative Approaches for Cancer Survivorship 2: Project 2 (IACS2)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized Manualized Health Education Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
  • Having received chemotherapy as part of their primary therapy for breast cancer
  • Be in complete remission
  • Aged 18 years or older
  • Able to read, write, and understand English
  • Karnofsky Performance Status (KPS) greater than or equal to 60
  • Have impaired quality of life
  • Ability to give informed consent

Exclusion Criteria:

  • Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
  • Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
  • Patients on adjuvant hormone therapy for less than 2 months
  • Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.

Sites / Locations

  • University of California, San Francisco, Osher Center for Integrative Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health Education Intervention

Arm Description

Study participants will attend Health Education sessions led by health educators over the course of 6 months. The emphasis in the sessions will be to provide engaging educational information on common survivorship issues.

Outcomes

Primary Outcome Measures

Change in quality of life over 6 months
The investigators will use the EORTC QLQ C30 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.

Secondary Outcome Measures

Change in fatigue over 6 months
The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
Change in sleep quality over 6 months
The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
Change in anxiety over 6 months
The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.
Change in depressive symptoms over 6 months
The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.
Change in pain over 6 months
The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.
Change in diet over 6 months
The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.

Full Information

First Posted
September 7, 2016
Last Updated
March 4, 2019
Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02897544
Brief Title
Integrative Approaches for Cancer Survivorship 2: Project 2
Acronym
IACS2
Official Title
Developing a Health Education Intervention for Breast Cancer Survivorship
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 4, 2018 (Actual)
Study Completion Date
June 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.
Detailed Description
Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. The investigators aim to develop and test a Health Education intervention in breast cancer survivors. Specifically, the investigators aim to develop the manualized Health Education intervention; to assess feasibility; and to provide preliminary data on the effects of the intervention. The data from this pilot study will be used to inform future study.

6. Conditions and Keywords

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

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 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Education Intervention
Arm Type
Experimental
Arm Description
Study participants will attend Health Education sessions led by health educators over the course of 6 months. The emphasis in the sessions will be to provide engaging educational information on common survivorship issues.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Manualized Health Education Intervention
Primary Outcome Measure Information:
Title
Change in quality of life over 6 months
Description
The investigators will use the EORTC QLQ C30 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in fatigue over 6 months
Description
The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
Time Frame
Baseline, 3 months, 6 months
Title
Change in sleep quality over 6 months
Description
The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
Time Frame
Baseline, 3 months, 6 months
Title
Change in anxiety over 6 months
Description
The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.
Time Frame
Baseline, 3 months, 6 months
Title
Change in depressive symptoms over 6 months
Description
The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.
Time Frame
Baseline, 3 months, 6 months
Title
Change in pain over 6 months
Description
The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.
Time Frame
Baseline, 3 months, 6 months
Title
Change in diet over 6 months
Description
The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) Having received chemotherapy as part of their primary therapy for breast cancer Be in complete remission Aged 18 years or older Able to read, write, and understand English Karnofsky Performance Status (KPS) greater than or equal to 60 Have impaired quality of life Ability to give informed consent Exclusion Criteria: Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary. Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary. Patients on adjuvant hormone therapy for less than 2 months Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Dhruva, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco, Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Integrative Approaches for Cancer Survivorship 2: Project 2

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