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| Name | Class |
|---|---|
| Conquer Cancer Foundation | OTHER |
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The purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer.
The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.
This two-part study will 1) refine and 2) pilot test an intervention to improve participant's and caregiver knowledge and increase communication with the oncology team about immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refine Intervention and Study Procedure | Experimental | Small open pilot (n=10) to refine the intervention and study procedures.
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| Educational Video and QPL List | Experimental | Randomized into Intervention Arm
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| Usual Care | Active Comparator | Randomized into Usual Care Arm
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Video and QPL List | Other | The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - enrollment | Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled | Day 1 |
| Feasibility, defined as completion of study activities | 80% of participants randomized to the intervention watch the video and review the QPL. | Baseline to 72 hours |
| Change in participant knowledge, using the Immunotherapy Knowledge Assessment | The primary outcome is participant knowledge, as measured by the Immunotherapy Knowledge Assessment, a 9-item survey with higher scores representing greater knowledge (minimum score = 0, maximum score =9). The investigators will compute the total knowledge score at baseline and 72 hours. | Baseline to 72 hours |
| Change in participant knowledge, using the Immunotherapy Knowledge Assessment | The primary outcome is participant knowledge, Immunotherapy Knowledge Assessment, a 9-item survey with higher scores representing greater knowledge (Minimum score = 0, maximum score = 9). The investigators will compute the total knowledge score at baseline and 6 weeks. | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory | The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 72 hours. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80). | Baseline to 72 hours |
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Inclusion Criteria:
All participants (Patients and Caregivers)-Table 1
Patient Inclusion Criteria (in addition to Table 1)
Caregiver Inclusion Criteria (in addition to Table 1)
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Laura A Petrillo, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39938469 | Derived | Petrillo LA, Hsu K, Pintro K, Rabideau DJ, Zhou AZ, Sarathy R, Tran A, Sullivan R, Reynolds KL, El-Jawahri A, Volandes A, Greer JA, Temel JS. Pilot Randomized Trial of an Educational Intervention About Immunotherapy for Patients With Advanced Cancer and Their Caregivers. J Natl Compr Canc Netw. 2025 Feb;23(2):12-20. doi: 10.6004/jnccn.2024.7079. |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| Usual Care | Other | Surveys |
|
| Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory |
The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 6 weeks. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80) |
| Baseline to 6 weeks |
| Patient questions asked in visit with oncologist | The number of questions asked by patients and caregivers will be assessed by coding the transcripts of audio-recorded oncology visits and compared between arms using the negative binomial model. | 72 hours |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015266 | Carcinoma, Merkel Cell |
| D002280 | Carcinoma, Basal Cell |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D008113 | Liver Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D001749 | Urinary Bladder Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018295 | Neoplasms, Basal Cell |
| D001941 | Breast Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D008107 | Liver Diseases |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
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