Question Prompt List for Gynecologic Cancer

(ASQ-GYO Trial)

Overseen By Elizabeth Johns, MD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ira Winer

Disqualifiers: Dysplasia, Non-cancer diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Question Prompt List for Gynecologic Cancer is an effective treatment?

The available research does not provide specific data on the effectiveness of the Question Prompt List for Gynecologic Cancer. The studies focus on other treatments and aspects of gynecologic cancer care, such as surgical strategies, chemotherapy, and quality of life measures, but do not mention the Question Prompt List or its impact on patient outcomes. ^{1 2 3 4 5}

What safety data exists for this treatment?

Research shows that women with gynecologic cancer may experience adverse events (unintended side effects) during treatment, especially if they have had previous treatments like surgery or chemotherapy. Monitoring tools and patient-reported outcomes can help track and manage these side effects to improve safety. ^{6 7 8 9 10}

How is the ASQ-GYO Question Prompt List treatment different from other treatments for gynecologic cancer?

The ASQ-GYO Question Prompt List is not a drug or a traditional medical treatment; instead, it is a tool designed to help patients ask important questions about their gynecologic cancer care, making it unique compared to standard medical treatments that focus on directly treating the cancer itself. ^{2 11 12 13 14}

Research Team

Ira S. Winer

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Eligibility Criteria

This trial is for new patients with various gynecologic cancers such as ovarian, cervical, endometrial, vulvar, and vaginal cancer. Participants should be those who are about to have their first oncology visit.

Inclusion Criteria

Understands spoken and written English

Able to consent to study participation

I have a confirmed or suspected gynecologic cancer and haven't seen a specialist.

Exclusion Criteria

History and/or imaging/laboratory findings more indicative of a non-cancer diagnosis

I have discussed my treatment options with a Gynecologic Oncologist.

My diagnosis is dysplasia in the cervix, vulva, or endometrium.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Visit Preparation

Participants are contacted to determine interest and consent method, and complete a pre-visit survey

1-2 weeks

1 contact (phone/email)

Intervention

Participants receive the ASQ-GYO QPL or usual care during their gynecologic oncology visit

1 day

1 visit (in-person)

Post-Visit Follow-up

Participants complete a post-visit survey and may receive the ASQ-GYO QPL if not initially provided

1 week

1 survey (online or in-person)

Follow-up

Participants are monitored for changes in self-efficacy, distress, trust, and knowledge

4 weeks

Treatment Details

Interventions

• ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List

Trial Overview The study tests if a special list of questions called the ASQ-GYO Question Prompt List can help patients feel more confident, less distressed, trust their doctor more, and understand their condition better compared to standard care.

Participant Groups

Group I: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List Experimental Treatment 1 Intervention

Participants are provided with a question prompt list

Group II: No administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List Active Control 1 Intervention

Participants will not be provided with the question prompt list

Who Is Running the Clinical Trial?

Ira Winer

Lead Sponsor

Trials

2

Recruited

130+

Findings from Research

Recent guidelines in gynecological oncology emphasize the importance of evaluating quality of life alongside treatment decisions, particularly in breast cancer, where sentinel lymph node dissection has shown to impact quality of life positively.

Targeted therapies, such as bevacizumab and everolimus, have been found to improve survival rates in ovarian and metastatic breast cancer patients without negatively affecting their quality of life, highlighting the potential for effective treatment strategies that also consider patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recent advances in patient-related outcome in gynaecological cancer]. Brachet, PE., Joly, F.[2015]

In ovarian cancer, new targeted agents like niraparib, cediranib, and nintedanib showed comparable efficacy in phase III trials, indicating promising options for treatment.

For cervical cancer, the nonavalent HPV vaccine demonstrated cost-effectiveness and potential for broader coverage, while the standard treatment for locally advanced cervical cancer was reaffirmed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major clinical research advances in gynecologic cancer in 2016: 10-year special edition. Suh, DH., Kim, M., Kim, K., et al.[2022]

The Society of Gynecologic Oncologists developed a comprehensive outcomes measure for endometrial cancer treatment, incorporating patient-reported data and assessments over a 120-day postoperative period, based on a study of 297 patients.

The tool aims to establish benchmarks for quality of care, showing that a high percentage of patients maintained independence post-surgery and reported high satisfaction scores, indicating effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Society of Gynecologic Oncologists Outcomes Task Force. Study of endometrical cancer: initial experiences. Kennedy, AW., Austin, JM., Look, KY., et al.[2019]

A study of 122 older gynecologic oncology patients, averaging 70.7 years old, revealed that their quality of life (QOL) scores were significantly lower in global health, social, role, and physical functioning compared to an age-matched general population.

Interestingly, these patients reported higher cognitive functioning scores than the general population, suggesting that while they face challenges in other areas of life, their cognitive abilities may remain relatively intact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life of older gynecologic oncology patients at the initiation of chemotherapy. Kleven, AG., Miaskowski, C., Torstveit, AH., et al.[2023]

The Gynecologic Cancer InterGroup (GCIG) emphasizes the need to integrate patient-reported outcome measures (PROMs) in ovarian cancer maintenance treatment trials to better support the primary endpoint of progression-free survival (PFS).

Four guiding principles were established for future trials, including adherence to SPIRIT-PRO guidelines and harmonization of PROM collection and reporting, which are essential for consistent assessment of patient-centered benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee. Kurtz, JE., Gebski, V., Sukhin, V., et al.[2021]

Women with gynecologic cancer experienced a higher mean number of total adverse events (AEs) during treatment (17.1) compared to women with nongynecologic cancer (14.7) and men with cancer (13.5), indicating a greater toxicity profile for this group.

Although the frequency of severe AEs (grade 3 to 5) was similar across all groups, women with gynecologic cancer had more frequent low-grade AEs (grade 2), suggesting a need for careful monitoring and potential dose adjustments to manage their symptom burden effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of toxicities related to novel therapy in clinical trials for women with gynecologic cancer. Lee, YC., Wang, L., Kohn, EC., et al.[2023]

A new worksheet developed for pharmacists helps track and analyze adverse reaction patterns in patients undergoing gynecologic cancer chemotherapy, improving the monitoring process.

The use of this worksheet has been shown to facilitate the detection of individual adverse reactions and prevent further complications, enhancing the safety and individualization of chemotherapy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Monitoring sheet covering long-term chemotherapy to predict individual adverse reaction patterns for patients with gynecologic chemotherapy]. Doi, C., Iihara, N., Kawazoe, H., et al.[2019]

In a study of 369 patients undergoing gynecological surgeries, 26% experienced adverse events (AEs), leading to an average additional hospitalization cost of AU$12,780 per patient.

Reducing AEs by 40% could potentially save the healthcare system up to AU$20.6 million per year, highlighting the importance of implementing evidence-based interventions to minimize these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital costs associated with adverse events in gynecological oncology. Kondalsamy-Chennakesavan, S., Gordon, LG., Sanday, K., et al.[2011]

A multi-method approach was used to develop a Patient-Reported Outcomes tool tailored for women with endometrial or ovarian cancer undergoing chemotherapy, identifying 21 relevant symptoms from the PRO-CTCAE library.

The final tool includes 44 items that assess the frequency, severity, and impact of these symptoms on daily activities, which can help in monitoring and managing adverse events during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy. Christiansen, MG., Pappot, H., Jensen, PT., et al.[2023]

A study involving 698 patients undergoing pelvic radiotherapy for gynecologic cancers showed that patient-reported outcome (PRO) questionnaires effectively tracked acute gastrointestinal and genitourinary toxicity, identifying patterns of onset and resolution.

The findings indicated that increased toxicity at week 2 could predict severe toxicity by week 5, highlighting the potential for using PRO data to improve patient care through early side effect management and real-time adjustments in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Weekly Patient-Reported Outcome Questionnaire to Track Acute Toxicity in Patients Undergoing Pelvic Radiotherapy for Gynecologic Cancers. Chan, M., Olson, R., Lapointe, V., et al.[2023]

Cervical cancer is a significant health issue in developing countries, where mortality rates are high, highlighting the urgent need for improved treatment and training for healthcare providers.

The paper discusses the inconsistencies in gynecologic oncology training in low- and middle-income countries (LMICs) and the challenges faced, aiming to inform future strategies for enhancing cancer care in these regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in gynecologic oncology training in low (LIC) and middle income (MIC) countries (LMICs): Common efforts and challenges. Johnston, C., Ng, JS., Manchanda, R., et al.[2022]

Annual screening for ovarian cancer using a multimodal strategy has shown high-level evidence of reducing ovarian cancer deaths, highlighting its potential efficacy in early detection.

Updates on cervical cancer vaccines, including a two-dose regimen and a 9-valent vaccine, indicate advancements in prevention strategies, while safety concerns regarding power morcellation in fibroid surgeries were reiterated, emphasizing the need for careful consideration in treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major clinical research advances in gynecologic cancer in 2015. Suh, DH., Kim, M., Kim, HJ., et al.[2018]

The 9-valent HPV vaccine has shown efficacy and safety in preventing cervical cancer, while updates on the quadrivalent vaccine indicate that a reduced dose may still have a long-term impact.

In ovarian cancer, advancements such as poly(ADP-ribose) polymerase inhibitors and immunotherapy are emerging as significant treatment options, alongside updates on surgical interventions and chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major clinical research advances in gynecologic cancer in 2017. Suh, DH., Kim, M., Lee, KH., et al.[2019]

A study of 85 gynecologic cancer survivors revealed a significant decline in sexual enjoyment, dropping from 64.7% before treatment to only 27.4% after, highlighting the impact of cancer therapy on sexual function.

Most patients (74.7%) preferred not to have healthcare providers initiate discussions about sexual health, often feeling that other issues were more important to address, indicating a need for improved communication strategies in oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual quality of life after the treatment of gynecologic cancer: what women want. Hubbs, JL., Dickson Michelson, EL., Vogel, RI., et al.[2020]

References

1. France pubmed.ncbi.nlm.nih.gov

[Recent advances in patient-related outcome in gynaecological cancer]. [2015]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Major clinical research advances in gynecologic cancer in 2016: 10-year special edition. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Society of Gynecologic Oncologists Outcomes Task Force. Study of endometrical cancer: initial experiences. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of life of older gynecologic oncology patients at the initiation of chemotherapy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of toxicities related to novel therapy in clinical trials for women with gynecologic cancer. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

[Monitoring sheet covering long-term chemotherapy to predict individual adverse reaction patterns for patients with gynecologic chemotherapy]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Hospital costs associated with adverse events in gynecological oncology. [2011]

9. Germany pubmed.ncbi.nlm.nih.gov

A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Using a Weekly Patient-Reported Outcome Questionnaire to Track Acute Toxicity in Patients Undergoing Pelvic Radiotherapy for Gynecologic Cancers. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Variations in gynecologic oncology training in low (LIC) and middle income (MIC) countries (LMICs): Common efforts and challenges. [2022]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Major clinical research advances in gynecologic cancer in 2015. [2018]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Major clinical research advances in gynecologic cancer in 2017. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

Sexual quality of life after the treatment of gynecologic cancer: what women want. [2020]