Breast CancerPROSPECTNCT02495155
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
A study testing PROSPECT in people with Breast Cancer and Fatigue, run by University of Michigan at 1 site in United States.
Trial summary
In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators'… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue, Insomnia
- What is being tested?
- PROSPECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2016
- 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
- Stage 0-III invasive carcinoma of the breast
- Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
- Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
- Must report at least one of the following:
- Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
Show all 11Show fewer
- Insomnia in the week prior to enrollment
- Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
- Has access to and is able to operate a computer with internet access.
- Able to read and understand English.
- Willing and able to sign an informed consent document.
Who cannot join
- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.
- Conditions
- Breast Cancer, Fatigue, Insomnia, Pain
- Being tested
- PROSPECT
- Medical subject headings
- Breast Neoplasms, Fatigue, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSPECTBehavioural
PROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms through non-pharmacologic approaches.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue | Active comparator | Participants who have received treatment for early stage breast cancer and who experience fatigue, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires. Receives: Behavioral: PROSPECT |
| Treatment-related Pain | Active comparator | Participants who have received treatment for early stage breast cancer and who experience pain, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires. Receives: Behavioral: PROSPECT |
| Insomnia | Active comparator | Participants who have received treatment for early stage breast cancer and who experience insomnia, assessed as difficulty sleeping over the last week, yes or no, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires. Receives: Behavioral: PROSPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in patient-reported symptom with use of PROSPECT for 8 weeks
To obtain preliminary data about the efficacy of the intervention in this patient population. The investigators will assess change in the participant's primary reported symptom (pain, insomnia, or fatigue) with 8 weeks of the intervention.
Measured: 8 weeks
Secondary outcomes (1)
Acceptability of the PROSPECT intervention based on patient self-report
To obtain preliminary data about the acceptability and usability of the intervention in this patient population.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
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 MichiganThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N. Lynn Henry, University of Michigan
- Investigators
- Norah L Henry, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495155
- Sponsor's protocol ID
- HUM00095498
- Acronym
- PROSPECT
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02495155
- Acronym / sponsor ID
- PROSPECT / HUM00095498
- Conditions
- Breast Cancer, Fatigue, Insomnia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jul 2015 (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.
In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fatigue | Active comparator | Behavioral: PROSPECTParticipants who have received treatment for early stage breast cancer and who experience fatigue, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires. |
| Treatment-related Pain | Active comparator | Behavioral: PROSPECTParticipants who have received treatment for early stage breast cancer and who experience pain, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires. |
| Insomnia | Active comparator | Behavioral: PROSPECTParticipants who have received treatment for early stage breast cancer and who experience insomnia, assessed as difficulty sleeping over the last week, yes or no, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- Stage 0-III invasive carcinoma of the breast
- Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
- Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
- Must report at least one of the following:
Key exclusion criteria (1 listed)
- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
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 |
|---|---|---|
| PROSPECTPROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms through non-pharmacologic approaches. | Behavioural | Fatigue, Insomnia, Treatment-related Pain |
Primary outcome
Improvement in patient-reported symptom with use of PROSPECT for 8 weeks
Time frame: 8 weeks
To obtain preliminary data about the efficacy of the intervention in this patient population. The investigators will assess change in the participant's primary reported symptom (pain, insomnia, or fatigue) with 8 weeks of the intervention.
1 secondary outcome
Acceptability of the PROSPECT intervention based on patient self-report
Time frame: 8 weeks
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 26 Jul 2016.
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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.
Norah L Henry, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROSPECT in people with Breast Cancer and Fatigue, run by University of Michigan 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 11 inclusion and 1 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 26 Jul 2016. 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?
Improvement in patient-reported symptom with use of PROSPECT for 8 weeks (time frame: 8 weeks). 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 26 Jul 2016.