Advanced Malignant MesotheliomaHOPENCT01126346
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
A study testing HIPEC Orientation, Consultation with Survivorship Navigator and Questionnaires in people with Advanced Malignant Mesothelioma and Carcinoma of the Appendix, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: An orientation and patient education program and telephone counseling may help improve the quality of life in patients with peritoneal surface malignancies. PURPOSE: This clinical trial studies quality of life and survivorship care in patients undergoing surgery and chemotherapy for peritoneal surface… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Malignant Mesothelioma, Carcinoma of the Appendix, Ovarian Sarcoma
- What is being tested?
- HIPEC Orientation, Consultation with Survivorship Navigator and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who undergo CS and HIPEC for peritoneal surface malignancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: HOPE Program: Quality of Life Enhancement and Survivorship Care
RATIONALE: An orientation and patient education program and telephone counseling may help improve the quality of life in patients with peritoneal surface malignancies.
PURPOSE: This clinical trial studies quality of life and survivorship care in patients undergoing surgery and chemotherapy for peritoneal surface malignancies.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population.
SECONDARY OBJECTIVES:
- Reduce pre-treatment distress and anxiety. II. Improve pre-treatment self-efficacy. III. Provide educational material delivered by the SRB. IV. Improve overall post-operative QOL ratings at 3 months, relative to discharge.
OUTLINE:
Patients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. . After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks, and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month.
- Conditions
- Advanced Malignant Mesothelioma, Carcinoma of the Appendix, Ovarian Sarcoma, Ovarian Stromal Cancer, Pseudomyxoma Peritonei, Recurrent Colon Cancer
- Being tested
- HIPEC Orientation, Consultation with Survivorship Navigator, Questionnaires
- Medical subject headings
- Appendiceal Neoplasms, Pseudomyxoma Peritonei, Colonic Neoplasms, Mesothelioma, Malignant, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPEC OrientationBehavioural
Also called orientation
Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
Consultation with Survivorship NavigatorBehavioural
Also called Consultation
Weekly psychosocial support via phone from Survivorship Navigator for 3 weeks prior to HIPEC; Inpatient consults occurring 3 to 4 days post-HIPEC and biweekly for 2 weeks and weekly until hospital discharge; Post-Hospital Discharge consults via phone twice per month for one month
QuestionnairesOther
Questionnaires Completed at 4 time points: T1 pre-HIPEC orientation, T2 with in 1 week of orientation, T3 1 month post HIPEC and T4 3 months post HIPEC. Questionnaires include Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI)
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month. Receives: Behavioral: HIPEC Orientation; Behavioral: Consultation with Survivorship Navigator; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population
Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI)
Measured: Baseline to 3 months post discharge
Secondary outcomes (4)
Reduce pre-treatment distress and anxiety
Compared t-tests will be conducted for the CESD and STAI (state anxiety subscale).
Measured: Pre-HIPEC to Day 0
Improve pre-treatment self-efficacy
Mean scores on the distress thermometer will be compared as well as individual patient changes.
Measured: Pre-HIPEC to Day 0
Provide educational material delivered by the SRB
Form to assess utility of the Survivorship Resource Book
Measured: Pre-HIPEC to Day 0
Improve overall post-operative QOL ratings at 3 months, relative to discharge
Improve post-operative QOL ratings at 3 months, relative to discharge. Repeated measures analysis of covariance (ANCOVA) will be utilized with the FACT scales.
Measured: 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant MesotheliomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard McQuellon, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126346
- Sponsor's protocol ID
- IRB00013172
- Other IDs
- NCI-2010-00980, CCCWFU 97110
- Acronym
- HOPE
- Status last verified
- Jul 2018
- First submitted
- 13 May 2010
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPE Program: Quality of Life Enhancement and Survivorship Care
- ClinicalTrials.gov ID
- NCT01126346
- Acronym / sponsor ID
- HOPE / IRB00013172
- Conditions
- Advanced Malignant Mesothelioma, Carcinoma of the Appendix, Ovarian Sarcoma, Ovarian Stromal Cancer, Pseudomyxoma Peritonei, Recurrent Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 May 2010 (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.
RATIONALE: An orientation and patient education program and telephone counseling may help improve the quality of life in patients with peritoneal surface malignancies.
PURPOSE: This clinical trial studies quality of life and survivorship care in patients undergoing surgery and chemotherapy for peritoneal surface malignancies.
Detailed description
PRIMARY OBJECTIVES:
- Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population.
SECONDARY OBJECTIVES:
- Reduce pre-treatment distress and anxiety. II. Improve pre-treatment self-efficacy. III. Provide educational material delivered by the SRB. IV. Improve overall post-operative QOL ratings at 3 months, relative to discharge.
OUTLINE:
Patients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. . After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks, and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Behavioral: HIPEC Orientation, Behavioral: Consultation with Survivorship Navigator, Other: QuestionnairesPatients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo CS and HIPEC for peritoneal surface malignancy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HIPEC OrientationAlso: orientationIntroduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session | Behavioural | Arm I |
| Consultation with Survivorship NavigatorAlso: ConsultationWeekly psychosocial support via phone from Survivorship Navigator for 3 weeks prior to HIPEC; Inpatient consults occurring 3 to 4 days post-HIPEC and biweekly for 2 weeks and weekly until hospital discharge; Post-Hospital Discharge consults via phone twice per month for one month | Behavioural | Arm I |
| QuestionnairesQuestionnaires Completed at 4 time points: T1 pre-HIPEC orientation, T2 with in 1 week of orientation, T3 1 month post HIPEC and T4 3 months post HIPEC. Questionnaires include Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI) | Other | Arm I |
Primary outcome
Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population
Time frame: Baseline to 3 months post discharge
Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI)
4 secondary outcomes
Reduce pre-treatment distress and anxiety
Time frame: Pre-HIPEC to Day 0
Improve pre-treatment self-efficacy
Time frame: Pre-HIPEC to Day 0
Provide educational material delivered by the SRB
Time frame: Pre-HIPEC to Day 0
Improve overall post-operative QOL ratings at 3 months, relative to discharge
Time frame: 3 months post discharge
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 3 Jul 2018.
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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.
Richard McQuellon principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIPEC Orientation, Consultation with Survivorship Navigator and Questionnaires in people with Advanced Malignant Mesothelioma and Carcinoma of the Appendix, run by Wake Forest University Health Sciences 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 1 inclusion and 0 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 3 Jul 2018. 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?
Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population (time frame: Baseline to 3 months post discharge). 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 3 Jul 2018.