PROM symptom tracker for Gynecologic Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan Rogel Cancer Center, Ann Arbor, MI
Gynecologic Cancers
PROM symptom tracker - Behavioral
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a text message survey can help patients recover at home after surgery.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PROM symptom tracker will improve 1 primary outcome and 5 secondary outcomes in patients with Gynecologic Cancers. Measurement will happen over the course of 30 days post-operative.

30 days post-operative
Proportion of patients readmitted to hospital
Proportion of patients seen in emergency room
Proportion of patients seen in urgent care clinics
Proportion of patients who called the care team
Proportion of patients who had non-standard clinic visits
30-32 days post-operative
Mean total score on FACT-G

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard Post-Operative Counseling + FACT-G (Control Arm)
1 of 2
Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm)
1 of 2
Active Control
Experimental Treatment

This trial requires 162 total participants across 2 different treatment groups

This trial involves 2 different treatments. PROM Symptom Tracker is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm)Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. The intervention arm will receive and complete the Patient-Reported Outcome Measure (PROM) survey via the SMS text messaging service on a set schedule. Patients will complete the FACT-G.
Standard Post-Operative Counseling + FACT-G (Control Arm)
Behavioral
Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. Patients will complete the Functional Assessment of Cancer Therapy - General (FACT-G).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30-32 days post-operative
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30-32 days post-operative for reporting.

Closest Location

University of Michigan Rogel Cancer Center - Ann Arbor, MI

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able to understand the information provided In a position to make a voluntary decision Capable of expressing consent Consenting individuals are willing and able to provide informed consent show original
You must be at least 18 years old to qualify. show original
I am planning to have surgery to treat a gynecologic cancer show original
The ability and willingness to send and receive short messaging service (SMS) text messages. show original
I can read and understand English. show original

Patient Q&A Section

What are common treatments for gynecologic cancers?

"Common treatments for gynecologic cancers include surgery, chemotherapy, radiation therapy, and a variety of other treatment options. Patient preferences are increasingly important in discussions regarding treatment options. Patient preferences can change with advancing cancer and can become part of the decision-making process." - Anonymous Online Contributor

Unverified Answer

What causes gynecologic cancers?

"Although many women receive early detection, the five most common gynecologic cancers are diagnosed at an advanced and late stage at which time treatment is often ineffective. Prevention and screening to detect cancers at an early stage might improve outcomes for these women." - Anonymous Online Contributor

Unverified Answer

Can gynecologic cancers be cured?

"The best treatment for most gynecologic malignancies is surgical excision, although often it is unresectable at the time of surgery. Aggressive treatment should be attempted when feasible because patients typically have a poor prognosis if surgery is not attempted. The chemotherapy regimen for locally advanced disease varies widely because of its toxicity and low curative percentage. Overall, for the vast majority of patients, surgical excision remains the definitive therapy and cure." - Anonymous Online Contributor

Unverified Answer

What is gynecologic cancers?

"Given recent advances in screening and prevention, it is projected that in the United States, there will be an estimated 49,800 new cases and 9,200 deaths from gynecologic cancers in 2010." - Anonymous Online Contributor

Unverified Answer

What are the signs of gynecologic cancers?

"The signs and symptoms of benign gynecologic conditions are similar to those of malignant ones, complicating preoperative diagnosis. In gynecologic cancers, there are few specific signs. The presence or absence of these signs can alter surgical strategy. For instance, in cervical cancer, pelvic pains and vaginal discharge are associated with advanced disease. In endometrial cancer, anemia, vaginal bleeding, and vaginal masses have been found to be associated with advanced disease. Ovarian cancer features include abdominal pain, decreased abdominal volume, distended abdomen/retroperitoneal lymphadenectomies affect peritoneal and intestinal symptoms, and peritoneal nodules may resolve spontaneously." - Anonymous Online Contributor

Unverified Answer

How many people get gynecologic cancers a year in the United States?

"About 3.3 million cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) were diagnosed to make it the most common cancer in American women. At the other end of the spectrum, an estimated 1.9 million cases of cervical cancer and 4.7 million cases of ovarian cancer are diagnosed each year." - Anonymous Online Contributor

Unverified Answer

Does gynecologic cancers run in families?

"There is only a limited amount of information available specifically about familial cancers of the cervix, endometrium, ovary and uterus. The overall aim of an updated review of this area is to shed light on how common any common variants and how they may operate in the etiology of both common and rare cancers of the cervix, endometrium, ovaries and uterus, in addition to providing information to oncologists about possible familial patterns of breast, gastrointestinal, ovarian and cervical cancers." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of gynecologic cancers?

"There may exist a large number of genetic factors involved in carcinogenesis, as reported in several epidemiological studies. Some studies hypothesize that cancer, either alone or in association, may be a consequence of an accumulation of somatic mutations after repeated exposure to high mutagenic levels of ionizing radiation or mutagenic chemicals. Other studies hypothesize that somatic mutation accumulation or epigenetic alterations as a consequence of exposure to some environmental mutagenic factor such as infectious agents, viruses, or other toxins that modify cancer risk." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating gynecologic cancers?

"Currently, there are very few treatments that can effectively treat gynecologic cancers in patients with a poor prognosis. Current research is focused on developing new treatment options. LHRH may serve as one possible option for ovarian cancer patients; studies by Semenza et al. provide evidence that anti-LHRH agonists can induce cell differentiation and inhibit growth of ovarian cancers. LHRH and its agonist LMB might present an alternative or adjuvant therapy for advanced ovarian cancer." - Anonymous Online Contributor

Unverified Answer

Has prom symptom tracker proven to be more effective than a placebo?

"In a recent study, findings show that neither Prom or BMS is significantly more effective than a placebo. Because of the ease of use and low side-effects, we recommend using Prom as a complementary tool for women with symptoms of hormonal imbalance." - Anonymous Online Contributor

Unverified Answer

What is the latest research for gynecologic cancers?

"More randomized controlled trials are needed. The quality of non-randomized studies in oncology, particularly when the cancer is not widely studied, has been inadequate. Randomized controlled trials have the potential to address many questions about treatment of gynecologic cancers." - Anonymous Online Contributor

Unverified Answer

Is prom symptom tracker typically used in combination with any other treatments?

"Data from a recent study does not allow the conclusion that any particular type of treatment is more effective than another for eliminating symptoms in women diagnosed with cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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