Breast CancerIACS2NCT02897544
Integrative Approaches for Cancer Survivorship 2: Project 2
A study testing Individualized Manualized Health Education Intervention in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Individualized Manualized Health Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 4 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco, Osher Center for Integrative Medicine
San Francisco, California, 94115
About this study
Official title: Developing a Health Education Intervention for Breast Cancer Survivorship
The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Individualized Manualized Health Education Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Manualized Health Education InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Health Education Intervention | Experimental | 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. Receives: Behavioral: Individualized Manualized Health Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (6)
Change in fatigue over 6 months
The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
Measured: Baseline, 3 months, 6 months
Change in sleep quality over 6 months
The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
Measured: Baseline, 3 months, 6 months
Change in anxiety over 6 months
The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Anand Dhruva, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897544
- Sponsor's protocol ID
- 16-1856
- Acronym
- IACS2
- Status last verified
- Mar 2019
- First submitted
- 7 Sep 2016
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Health Education Intervention for Breast Cancer Survivorship
- ClinicalTrials.gov ID
- NCT02897544
- Acronym / sponsor ID
- IACS2 / 16-1856
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2016
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Education Intervention | Experimental | Behavioral: Individualized Manualized Health Education InterventionStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Manualized Health Education Intervention | Behavioural | Health Education Intervention |
Primary outcome
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.
6 secondary outcomes
Change in fatigue over 6 months
Time frame: Baseline, 3 months, 6 months
Change in sleep quality over 6 months
Time frame: Baseline, 3 months, 6 months
Change in anxiety over 6 months
Time frame: Baseline, 3 months, 6 months
Change in depressive symptoms over 6 months
Time frame: Baseline, 3 months, 6 months
Change in pain over 6 months
Time frame: Baseline, 3 months, 6 months
Change in diet over 6 months
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Dhruva, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Manualized Health Education Intervention in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life over 6 months (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.