Skip to main content
OpenTrials
Completed

NCT Number: NCT02897544

Integrative Approaches for Cancer Survivorship 2: Project 2

The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized Manualized Health Education Intervention

Behavioral

Primary outcomes

  1. Change in quality of life over 6 months

    Time frame: Baseline, 3 months, 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 outcomes

  1. Change in fatigue over 6 months

    Time frame: Baseline, 3 months, 6 months

    The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.

  2. Change in sleep quality over 6 months

    Time frame: Baseline, 3 months, 6 months

    The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.

  3. Change in anxiety over 6 months

    Time frame: Baseline, 3 months, 6 months

    The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.

  4. Change in depressive symptoms over 6 months

    Time frame: Baseline, 3 months, 6 months

    The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.

  5. Change in pain over 6 months

    Time frame: Baseline, 3 months, 6 months

    The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.

  6. Change in diet over 6 months

    Time frame: Baseline, 3 months, 6 months

    The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Developing a Health Education Intervention for Breast Cancer Survivorship

Acronym: IACS2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2016
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.