Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Endometrial Neoplasms

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Aromatase Inhibitors

Progesterone

Antineoplastic Agents, Hormonal

Progestins

Hormones

Hormone Antagonists

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Enzyme Inhibitors

Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy

Hormonal therapy used for treatment in endometrial cancer patients

Hormonal Antineoplastics

Maartje Luijten, MD

Hanny Pijnenborg, MD PhD

Maartje Luijten

Hanny Pijnenborg

Roy Lalisang, MD PhD prof

Andrea Romano, MD PhD

Willem Jan Van Weelden, MD

The PROMOTE study aims at optimising use of hormonal therapy in advanced stage and recurrent endometrial cancer analysing tumor tissue taken before start of hormonal therapy

There is limited consensus about the position of hormonal treatment in advanced and metastatic endometrial carcinoma (EC). This is due to lack of good quality data on patient selection, and predictive biomarkers. Consequently, consideration of hormonal therapy is subjected to personal experience of the treating physician, rather than on refined clinical and up-to-date molecular criteria. Hormonal therapy has limited side-effects, and is better tolerated than systematic chemotherapy. Since EC patients are often elderly women with comorbidities, more effective and less aggressive treatment options are needed, underlining the urgency of an explorative study on this topic.

Endometrial cancer is the most common malignancy of the female genital tract in developed countries, with increasing incidence due to obesity and increased life expectancy. Most patients are diagnosed at an early stage, and have a favourable prognosis with surgery alone. Yet, 20% of the patients present with advanced or metastatic EC and have a poor outcome even with systemic treatment. Response rate of chemotherapy in advanced or metastatic EC is 30-60%, dependent of previous chemotherapy, with a progression free survival (PFS) of 3-14 months and 40% treatment related morbidity. In comparison, response to hormonal therapy is 20%-40%, with side effects in less than 5%. The overall PFS is 3 months, yet for those who respond the PFS can be up to several years.

To improve selective use of hormonal therapy in EC by evaluating applied hormonal therapy in advanced and metastatic EC and correlate response to molecular tumour analysis and translate this knowledge after validation into clinical practice

Tumor samples originating from before start of hormonal therapy

PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer

Complete or partial response according to RECIST criteria

Interval from start of hormonal therapy to progressive disease or death

Complete or partial response or stable disease according to RECIST criteria

Health-related quality of life during hormonal therapy as tested with the validated EORTC-QLQ-C30 and EORTC-QLQ-EN24 quality-of-life scales at start of hormonal therapy and 6 months after start therapy

Haukeland University Hospital

Maastricht University Medical Center

Brno University Hospital

Holycross Cancer Center Kielce

Medical University of Lublin

Hospital del Mar

Hospital Vall d'Hebron

Royal Cornwall Hospitals Trust

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

The Netherlands Cancer Institute

Canisius-Wilhelmina Hospital

Catharina Ziekenhuis Eindhoven

Erasmus Medical Center

Leiden University Medical Center

Radboud University Medical Center

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Cervical Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Vulvar Cancer

Participants randomized to the intervention will receive the Strong Together serious game program on a tablet computer. The goal of this serious game is to teach the participant how to advocate for her needs relate to her cancer and treatment. The research team will send participants weekly notifications for 12 weeks to alert them that a new serious game session is available and encourage them to complete one session per week.

If randomized to the enhanced care as usual arm, the research team will give participants a paper-based self-advocacy patient brochure published by the National Coalition for Cancer Survivorship. This guide is not a part of usual care, but is freely available on the Internet.

The Strong Together serious game program is an interactive, immersive education program in which participants quickly learn the behaviors of self-advocacy and the potential consequences of self-advocating or not. Participants will receive weekly game sessions to play at home for three months.

Strong Together serious game

Teresa H Thomas, PhD, RN

Self-advocacy, defined as the ability of a patient to get her needs and priorities met in the face of a challenge, is an essential skill but not all women with advanced cancer are able to do it. We want to instruct women with advanced cancer who have low self-advocacy to self-advocate for their health and well-being. We will test a new "serious game" or video program that teaches self-advocacy skills through interactive, situation-based activities. The goal of the Strong Together serious game is to engage participants in challenges commonly experienced by women with advanced cancer, offer them choices to self-advocate or not, and directly show them the health and social benefits of self-advocating and the negative consequences of not self-advocating. Through engaging in the Strong Together program, participants vicariously learn the essential skills of self-advocacy, understand the downstream effects of using or not using these skills, and learn distinct behaviors that they can then use to address their own challenges.

Background: When faced with the challenges of advanced cancer, women must advocate (or stand up) for their needs and priorities. However, there are no interventions to promote self-advocacy among female patients with advanced cancer. Preliminary work has developed a theoretically-based, psychometrically-strong measure of self-advocacy (the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale) and demonstrated correlations with symptom burden and healthcare utilization. Serious games offer a novel mechanism by which to deliver interactive, engaging health education that links users' choices to consequences so that users learn a desired skill. The fully-automated Strong Together self-advocacy serious game may allow women with advanced cancer to learn self-advocacy skills and therefore improve their health outcomes.

Objective/Hypothesis: The purpose of this pilot randomized controlled trial (RCT) is to evaluate the feasibility, acceptably, and preliminary efficacy of the Strong Together serious game.

Specific Aims:

Specific Aim 1: To evaluate the feasibility and acceptability of the 3-month Strong Together intervention.

* Benchmark 1: At least 75% of participants will engage in at least 8 out of the 12 serious game sessions.
* Benchmark 2: At least 80% of participants will find the intervention acceptable based on ratings of perceived satisfaction and ease of use, as well as feedback from qualitative exit interviews.

Specific Aim 2: To explore the differences in self-advocacy and symptom burden between groups over time.

• Research Question: Do patients who receive the intervention report improved self-advocacy and lower symptom burden compared to those assigned to enhanced care as usual?

Study Design: This pilot RCT will recruit (N=84) women from cancer clinics at the University of Pittsburgh Medical Center. Eligibility criteria include: female; age ≥ 18 years; diagnosis of Stage III or IV gynecological or Stage IV breast cancer within the past 3 months; 6-month prognosis; Eastern Cooperative Oncology Group score of 0-1; and ability to read and write in English. Measures will be collected at baseline, 3 months, and 6 months. Randomization (2:1) will occur to the 3-month Strong Together intervention group or the enhanced care as usual group. Feasibility will be assessed by calculating percentages of the intervention's dosage, engagement, recruitment, retention, and data completion. Acceptability will be assessed through exit interviews and an acceptability scale. Preliminary efficacy will be measured by exploring differences in self-advocacy and symptom burden scores and calculating point and interval estimates between the groups at 3 and 6 months.

Cancer Relevance: This study represents a unique opportunity to address the lack of self-advocacy interventions, reduce the risks of women with low self-advocacy, and guide an adequately-powered RCT to educate women with advanced cancer to self-advocate.

Inclusion criteria are based on cancer diagnoses which primarily occur in women (gynecological and breast cancer).

Self-Advocacy Serious Game in Advanced Cancer

Piloting a Serious Game to Improve Self-Advocacy Among Women With Advanced Cancer

We will calculate the number of participants in the intervention group who complete two-thirds (66.7%) of the intervention sessions as a measure of intervention feasibility. We will accept that we achieved adequate feasibility if at least 75% of participants engage in at least eight out of the twelve serious game sessions.

We will accept that we achieved adequate acceptability if at least 80% of participants find the intervention acceptable based on the Post Study System Usability Questionnaire scores and if no issues are raised during the qualitative interviews and feedback that cannot be revised prior to the future trial.

We anticipate that self-advocacy scores will increase (improve) among participants in the intervention group compared to the enhanced care as usual group.

We anticipate that symptom burden scores will decrease (improve) among participants in the intervention group compared to the enhanced care as usual group.

We anticipate that the frequency of healthcare utilization will decrease (improve) among participants in the intervention group compared to the enhanced care as usual group.

We anticipate that quality of life will increase (improve) among participants in the intervention group compared to the enhanced care as usual group.

University of Pittsburgh

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center
Self-Advocacy Serious Game in Advanced Cancer	NCT03339765	Ovarian Cancer ... Ovarian Cancer ... Breast Cancer S... Cervical Cancer... Cervical Cancer... Cervical Cancer... Endometrial Can... Endometrial Can... Vulvar Cancer, ... Vulvar Cancer, ... Vaginal Cancer ... Vaginal Cancer ... Vaginal Cancer ...	Strong Together...	18 Years -	University of Pittsburgh
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center

Spots Global Cancer Trial Database for endometrial cancer stage iii