Psychological AdaptationNCT04815746
QOL and GI Outcomes in Malignancies
A study testing Cognitive Behavioral Therapy (CBT)-based skills and Standard Education in people with Psychological Adaptation and Psychological Adjustment, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Adaptation, Psychological Adjustment, Stress, Emotional
- What is being tested?
- Cognitive Behavioral Therapy (CBT)-based skills and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 8 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age
- Spanish or English speaker with ability to read one of these languages
- Diagnosis of pancreatic cancer .
- Willingness to be assessed at diagnosis, during neoadjuvant chemotherapy (if applicable), preoperatively (if applicable - unless time of diagnosis is preoperative visit), and postoperatively for up to two years following surgery.
Who cannot join
- Patients unable to read Spanish or English, as they will be unable to complete surveys.
- History of previous invasive cancer or treatment with chemotherapy, as they may have a different baseline functional status, quality of life, and gastrointestinal function compared to the normal healthy population, per principal investigator discretion, based on a case-by-case review.
- Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months as these conditions can interfere with adequate participation in assessments, per principal investigator discretion, based on a case-by-case review.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
- Being tested
- Cognitive Behavioral Therapy (CBT)-based skills, Standard Education
- Keywords
- Psychosocial Symptom Management, eHealth Intervention
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)-based skillsBehavioural
The CBT skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour.
Standard EducationBehavioural
Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm | Experimental | Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period. Receives: Behavioral: Cognitive Behavioral Therapy (CBT)-based skills |
| Usual Clinical Care Control Arm | Active comparator | Participants in this group will receive standard education. Receives: Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life as Measured by Perceived Stress Scale
Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress)
Measured: Up to 10 weeks.
Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale
UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness)
Measured: Up to 10 weeks.
Health Related Quality of Life as Measured by Interpersonal Support Evaluation List
Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support).
Measured: Up to 10 weeks.
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)
FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life)
Measured: Up to 10 weeks.
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life)
Measured: Up to 10 weeks.
The Gastrointestinal Symptom Rating Scale (GSRS)
GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)
Measured: Up to 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Oct 2024 (estimated)
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Why it stopped: We have decided to withdraw this research study due to the receipt of funding for a similar study that aligns more closely with our current research priorities and available resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological AdaptationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank Penedo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815746
- Sponsor's protocol ID
- 20190846
- Status last verified
- Nov 2024
- First submitted
- 22 Mar 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies
- ClinicalTrials.gov ID
- NCT04815746
- Acronym / sponsor ID
- 20190846
- Keywords
- Psychosocial Symptom Management, eHealth Intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We have decided to withdraw this research study due to the receipt of funding for a similar study that aligns more closely with our current research priorities and available resources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 25 Mar 2021 (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 purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)-based skillsParticipants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period. |
| Usual Clinical Care Control Arm | Active comparator | Behavioral: Standard EducationParticipants in this group will receive standard education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than 18 years of age
- Spanish or English speaker with ability to read one of these languages
- Diagnosis of pancreatic cancer .
- Willingness to be assessed at diagnosis, during neoadjuvant chemotherapy (if applicable), preoperatively (if applicable - unless time of diagnosis is preoperative visit), and postoperatively for up to two years following surgery.
Key exclusion criteria (4 listed)
- Patients unable to read Spanish or English, as they will be unable to complete surveys.
- History of previous invasive cancer or treatment with chemotherapy, as they may have a different baseline functional status, quality of life, and gastrointestinal function compared to the normal healthy population, per principal investigator discretion, based on a case-by-case review.
- Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months as these conditions can interfere with adequate participation in assessments, per principal investigator discretion, based on a case-by-case review.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
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 (CBT)-based skillsThe CBT skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour. | Behavioural | Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm |
| Standard EducationPatients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer. | Behavioural | Usual Clinical Care Control Arm |
Primary outcome
Health Related Quality of Life as Measured by Perceived Stress Scale
Time frame: Up to 10 weeks.
Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress)
Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale
Time frame: Up to 10 weeks.
UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness)
Health Related Quality of Life as Measured by Interpersonal Support Evaluation List
Time frame: Up to 10 weeks.
Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support).
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)
Time frame: Up to 10 weeks.
FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life)
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
Time frame: Up to 10 weeks.
FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life)
The Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Up to 10 weeks.
GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- 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.
Frank Penedo, PhD principal investigator
University of Miami
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 (CBT)-based skills and Standard Education in people with Psychological Adaptation and Psychological Adjustment, run by University of Miami 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 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: withdrawn, as of the sponsor's last update on 26 Nov 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 was withdrawn before enrolling participants, so there are no results.
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?
Health Related Quality of Life as Measured by Perceived Stress Scale (time frame: Up to 10 weeks.). The study lists 6 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 26 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.