Breast CancerNCT06604247
The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients
A study testing Cognitive Behavioral therapy for insomnia (CBT-I) in people with Breast Cancer and Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- Cognitive Behavioral therapy for insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 30 Jun 2024
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of organ-confined breast cancer or prostate cancer
- Received radiation treatment
- Willing and able to provide informed consent
- Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory
Who cannot join
- History of obstructive Sleep Apnea
- History of narcolepsy
- Night shift work
- Distant metastatic disease at presentation
- Active drug/alcohol dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Pennsylvania, Behavioral Sleep Medicine Program
Philadelphia, Pennsylvania, 19104
About this study
The objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Ultimately, this research will help to develop a better understanding of the underlying mechanisms of cancer related fatigue.
Read the detailed description
Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to decreases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- Cognitive Behavioral therapy for insomnia (CBT-I)
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral therapy for insomnia (CBT-I)Behavioural
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
| Study group | Role | What they receive |
|---|---|---|
| 4-session | Experimental | Participants randomized to this condition received 4 weekly CBT-I sessions. Receives: Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I) |
| 8-session | Experimental | Participants randomized to this condition received 8 weekly CBT-I sessions. Receives: Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I) |
| 10-session | Experimental | Participants randomized to this condition received 10 weekly CBT-I sessions. Receives: Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I) |
| 12-session | Experimental | Participants randomized to this condition received 12 weekly CBT-I sessions. Receives: Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale.
Measured: From enrollment to three months post-treatment
Insomnia Severity
As measured by the Insomnia Severity Index
Measured: From enrollment to post-treatment, and 3 months post-treatment
Secondary outcomes (1)
Sleep Continuity
As measured by the daily sleep diary, including sleep latency, number of awakenings, wake after sleep onset, total sleep time and sleep efficiency.
Measured: From enrollment to post-treatment, and 3 months post-treatment.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2020
- Primary completion1 Oct 2023
- Study completion30 Jun 2024
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 Abramson Cancer Center at Penn MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604247
- Sponsor's protocol ID
- 834620
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06604247
- Acronym / sponsor ID
- 834620
- Conditions
- Breast Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- 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 objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Ultimately, this research will help to develop a better understanding of the underlying mechanisms of cancer related fatigue.
Detailed description
Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to decreases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4-session | Experimental | Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)Participants randomized to this condition received 4 weekly CBT-I sessions. |
| 8-session | Experimental | Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)Participants randomized to this condition received 8 weekly CBT-I sessions. |
| 10-session | Experimental | Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)Participants randomized to this condition received 10 weekly CBT-I sessions. |
| 12-session | Experimental | Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)Participants randomized to this condition received 12 weekly CBT-I sessions. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of organ-confined breast cancer or prostate cancer
- Received radiation treatment
- Willing and able to provide informed consent
- Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory
Key exclusion criteria (5 listed)
- History of obstructive Sleep Apnea
- History of narcolepsy
- Night shift work
- Distant metastatic disease at presentation
- Active drug/alcohol dependence
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 |
|---|---|---|
| Cognitive Behavioral therapy for insomnia (CBT-I)Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration. | Behavioural | 10-session, 12-session, 4-session, 8-session |
Primary outcome
Fatigue
Time frame: From enrollment to three months post-treatment
Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale.
Insomnia Severity
Time frame: From enrollment to post-treatment, and 3 months post-treatment
As measured by the Insomnia Severity Index
1 secondary outcome
Sleep Continuity
Time frame: From enrollment to post-treatment, and 3 months post-treatment.]
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral therapy for insomnia (CBT-I) in people with Breast Cancer and Prostate Cancer, run by Abramson Cancer Center at Penn Medicine 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 4 inclusion and 5 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 19 Sep 2024. 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?
Fatigue (time frame: From enrollment to three months post-treatment). The study lists 2 primary outcomes in all. 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 19 Sep 2024.